Detection of Heterogeneity in Central Lung Cancer - EBUS-TBNA and ctDNA Analysis vs. Endobronchial Forceps Biopsy

Not Applicable

Completed

• Conditions: Lung Neoplasms
• Interventions: Procedure: EBUS-TBNA; Procedure: Endobronchial forceps biopsy

• Registration Number: NCT03017183
• Lead Sponsor: Wissenschaftliches Institut Bethanien e.V

Brief Summary

Study participants will be selected from clinical routine patients with endobronchial infiltration of a central lung cancer and indication for bronchoscopic sampling.

Consented patients will undergo bronchoscopy for tumor sampling applying two routine sampling methods during one single procedure (EBUS-TBNA and conventional forceps sampling). The sequence of both sampling methods will be randomized in advance.

The resulting tissue samples will be analyzed by a pathologist using multiplex PCR and FISH. The corresponding analysis results will be compared between sampling methods.

Assignment of a subject to a particular therapeutic strategy is not influenced by this protocol. Medicinal products will be used according to current practice and marketing authorisation.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-02
• Study First Submitted: 2017-01-05
• Study First Submitted QC: 2017-01-10
• Study First Posted: 2017-01-11
• Primary Completion: 2017-07-31
• Study Completion: 2017-07-31
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-26
• Last Update Posted: 2018-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EBUS-TBNA - Endobrochial Forceps Biopsy	EBUS-TBNA	In this arm, EBUS-TBNA will be done first, followed by endobronchial forceps biopsy
Forceps - EBUS-TBNA	EBUS-TBNA	In this arm, endobronchial forceps biopsy will be done first, followed by EBUS-TBNA
Forceps - EBUS-TBNA	Endobronchial forceps biopsy	In this arm, endobronchial forceps biopsy will be done first, followed by EBUS-TBNA
EBUS-TBNA - Endobrochial Forceps Biopsy	Endobronchial forceps biopsy	In this arm, EBUS-TBNA will be done first, followed by endobronchial forceps biopsy

Primary Outcome Measures

Name	Time	Method
Number of detected mutations	within 7 days after biopsy	The number of different mutations detected based on each biopsy method as well as ctDNA analysis is determined

Trial Locations

Locations (1)

Krankenhaus Bethanien gGmbH; 🇩🇪 Solingen, NRW, Germany